Injectable silicone biomaterial for faecal incontinence due to internal anal sphincter dysfunction.

BACKGROUND: A weak or disrupted internal anal sphincter can cause passive faecal incontinence. Conservative measures may help some patients but there is no simple surgical solution for those who fail conservative treatment. A successful technique using trans-sphincteric injection of a bulking agent to augment the internal anal sphincter was developed in a previous pilot study. AIM: To determine the clinical results and underlying physiological effects of biomaterial injection. PATIENTS: Six patients (four males, median age 53 years (range 36-65)) with faecal incontinence to solid or liquid stool related to poor internal anal sphincter function, of varied aetiology, were recruited. METHODS: Silicone based biomaterial injections were performed, under local anaesthesia, with antibiotic cover. Three injections were placed circumferentially, trans-sphincterically, entering away from the anal margin and injecting at or just above the dentate line. Anorectal physiological studies, endoanal ultrasound, a bowel symptom diary, a validated incontinence score, and quality of life questionnaires were completed before treatment and on completion of follow up. RESULTS: At a median follow up of 18 months (range 15-19), five of six patients had marked symptom improvement. Faecal incontinence scores improved from a median of 14/24 (range 11-20) before to 8/24 (6-15) after injection. Short form-36 quality of life physical and social function scores improved from a median of 26/100 (5-33) to 79/100 (25-100) and from 10/100 (5-37) to 100/100 (50-100), respectively. There was a corresponding physiological increase in maximum anal resting and squeeze pressures. Ultrasound showed the Bioplastique to be retained in the correct position in the improved patients without migration. There were no complications. CONCLUSION: Trans-sphincteric injection of silicone biomaterial can provide a marked improvement in faecal incontinence related to a weak or disrupted internal anal sphincter. This is associated with improved sphincter function and quality of life.

A prospective audit of fistula-in-ano at St. Mark's hospital.

OBJECTIVE: To conduct a prospective audit of all patients presenting with anal fistula at St. Mark's Hospital during one calendar year and to compare the presentation and outcome of this cohort with previous reports from this institution. PATIENTS AND METHODS: All patients undergoing examination under anaesthetic (EUA) for anal fistula during 1997 were studied. All fistulae were anatomically classified and operative procedures recorded. During a mean follow-up period of 14 months details of healing, recurrence and function were gathered. RESULTS: 98 patients with a mean age of 43.7 years were assessed. 86 (88%) patients had fistulae of cryptoglandular (idiopathic) origin. Fistulae were superficial in 11 (11%) patients, intersphincteric in 30 (31%) patients, trans-sphincteric in 52 (53%) patients, suprasphincteric in 3 (3%) patients and extra-sphincteric in 2 (2%) patients. 49 (50%) fistulae were classified as complex. Eradication of fistulae with preservation of function was achieved in 89 (91%) patients. Fistula recurrence occurred in 4 (4%) cases. Ten (10%) patients had some degree of incontinence, 9 (9%) of whom had undergone previous fistula surgery. Nine (9%) patients still had setons in situ at the end of the follow-up period. CONCLUSIONS: A greater proportion of difficult fistulae was seen during the year compared with previous studies from St. Mark's. Despite this a satisfactory outcome was achieved in the vast majority with a relatively low rate of disturbed function. Previous fistula surgery is a risk factor for incontinence, which can usually be managed conservatively.

Clinical and economic evaluation of surgical treatments for faecal incontinence.

BACKGROUND: Faecal incontinence affects 1-2 per cent of the adult population. While many patients can be managed successfully with conservative therapy, a small proportion require surgery. Improved imaging techniques and technological advances have led to the availability of a wide range of surgical treatments. Decision-makers increasingly require clinical and cost-effectiveness studies of surgical treatments for faecal incontinence. This review examines the practical aspects of undertaking such studies. METHODS: The practical issues related to different aetiologies, different types of treatment, defining outcomes, the hidden costs of the condition and its treatment, the rapid changes in technology and issues of patient choice were all considered. A Medline search was undertaken to identify relevant publications, and the reference lists of identified papers were scanned manually. RESULTS: There are few randomized controlled studies and those that have been performed have been limited in their scope. There has also been very limited health economic analysis undertaken. Strategies for conducting such studies, and the criteria they use, have been outlined. CONCLUSION: Randomized trials have a limited role in this setting because of variations in aetiology, difficulty in standardizing procedures, continuing evolution of devices, small patient numbers, concerns for patient choice and the need for long-term follow-up. Issues to be addressed when evaluating interventions for faecal incontinence include choosing appropriate measures of surgical outcome, using new continence scoring systems and tools for quality-of-life assessment, and choosing appropriate cost perspectives and time horizons for economic evaluation.

Assessment of external anal sphincter morphology in idiopathic fecal incontinence with endocoil magnetic resonance imaging.

The failure of external anal sphincter repair may relate to sphincter atrophy where muscle fibers are replaced by fat, seen on MRI due to the differing signals returned by fat and muscle tissue. Manometry, electrophysiology, and MRI with an endocoil were performed on 34 fecally incontinent patients with intact sphincters on endosonography. The area of the external sphincter was measured in the midcoronal plane, and the percentage fat content calculated. Sphincter muscle area correlated strongly with squeeze pressure (P < 0.001) but not with percentage fat content. There was no relationship between percentage fat and age, weight, anal sensation, squeeze pressure, sphincter length or width, or pudendal nerve terminal motor latency. There was a trend for smaller sphincters to contain a higher percentage fat content (P = 0.059). MRI has established a relationship between function and external sphincter bulk, but not fat content, although smaller muscles may contain more fat.

Fecal incontinence.

Fecal incontinence is common and socially disabling. Only a few patients with fecal incontinence present to medical practitioners. Investigative techniques have improved, and it is possible now to define accurately functional or anatomic deficits. Careful planning of treatment with the possibility of using a variety of treatment modalities is essential. Novel conservative and surgical techniques have the potential to improve the outcome for patients with fecal incontinence.

Internal anal sphincter augmentation for fecal incontinence using injectable silicone biomaterial.

PURPOSE: A disrupted or weak internal anal sphincter can lead to passive fecal incontinence. This muscle is not amenable to direct surgical repair. Previous preliminary attempts to restore functional continuity have included a cutaneous flap to fill an anal canal defect, and injection therapy using polytetrafluoroethylene, collagen, or autologous fat. Urologists have also used injections of collagen or silicone to enhance bladder neck function. This pilot study aimed to assess the efficacy of single or multiple injections of the silicone-based product Bioplastique for the symptoms of passive fecal incontinence caused by an anatomically disrupted or intact but weak internal anal sphincter. PATIENTS AND METHODS: Ten patients (6 females; median age, 64, range, 41-80 years) with passive incontinence secondary to a weak (n = 6) or disrupted (n = 4) internal anal sphincter were injected either circumferentially or at a single site, respectively. Patients were assessed before and six weeks after treatment by clinical assessment, two-week bowel diary card, anorectal physiologic testing, and endoanal ultrasound. Patients failing to show improvement after the first injection were offered a second injection six weeks after the first injection. Clinical assessment was further repeated at six months, and five patients had a further ultrasound examination. RESULTS: At six weeks, six of ten patients showed either marked improvement (n = 3) or complete cessation of leakage (n = 3). A further patient was greatly improved after a second injection. Three patients were not improved. At six months, two of the seven patients had maintained marked improvement, and one patient had maintained minor improvement; all of these three patients had circumferential multiple injections. Maximum resting and squeeze anal pressures did not differ significantly between before vs. six weeks after vs. six months after injection. At six weeks endoanal ultrasound (n = 9) confirmed the presence and correct position of the silicone in all but one patient who had experienced obvious external leakage of the product. At six months the silicone remained in the correct position in the five endosonographically assessed patients. Five of the initial patients experienced pain or minor ulceration at the injection site. CONCLUSIONS: Although clinically effective immediately after injection, the benefit of an injectable biomaterial was maintained in only a minority of patients. This occurred despite the continued presence of material in the correct anatomical site. Patients with diffuse weakness treated by circumferential injection seemed to be the most responsive, but further studies are required to clarify this.

Implementation of the STOP protocol for Stroke Prevention in Sickle Cell Anemia by using duplex power Doppler imaging.

PURPOSE: To compare the results of the nonduplex ultrasonography (US) Stroke Prevention Trial in Sickle Cell Anemia (STOP) with those of transcranial duplex power Doppler US by using the STOP protocol and to correlate abnormal transcranial Doppler findings with magnetic resonance (MR) imaging and MR angiographic findings. MATERIALS AND METHODS: One hundred twenty-five asymptomatic patients aged 2-16 years with sickle cell anemia or sickle cell-beta thalassemia were examined by using transcranial duplex power Doppler US with a 2.5-MHz transducer and classified according to STOP criteria. The results were compared with those obtained in the nonduplex STOP study. Eight of 10 patients with abnormal results, as well as one who had normal results and a subsequent stroke, were examined with MR imaging and MR angiography. RESULTS: Ten (8.0%) patients were judged to have abnormal findings by using the duplex Doppler US and STOP criteria compared with 9.4% of patients in the nonduplex US STOP study. Of the eight patients with abnormal transcranial Doppler US results who underwent MR imaging and MR angiography, six had abnormal MR imaging findings and all eight had abnormal MR angiographic findings. CONCLUSION: The STOP protocol can be reproduced by using duplex power Doppler US. Abnormal results with the STOP criteria strongly suggest vascular abnormality.

Prospective assessment of interobserver agreement for endoanal MRI in fecal incontinence.

BACKGROUND: Endoanal magnetic resonance (MR) imaging is a new technique for the assessment of anal sphincter integrity in fecal incontinence and an alternative to anal endosonography. The present study aimed to determine interobserver variation for assessment of anal sphincter integrity using endoanal MR imaging. METHODS: Fifty-two consecutive anally incontinent patients underwent MR imaging by using a purpose-built endoanal receiver coil and static 1.0-T magnet. T2-weighted axial, coronal, and sagittal scans were independently assessed by two radiologists who noted external and internal sphincter integrity. Findings were compared and agreement was assessed with the kappa statistic. RESULTS: There was disagreement in 18 of 49 technically adequate studies (37%; kappa = 0.46), indicating "moderate" agreement. Agreement was strongest if the sphincters were either both intact or both disrupted. Observers agreed in only one diagnosis of an isolated internal sphincter defect and in no diagnosis of an isolated external sphincter defect. CONCLUSION: The overall interobserver agreement for assessment of sphincter integrity using endoanal MR imaging is "moderate." Interobserver agreement using endoanal MR imaging is less than that reported for anal endosonography.

Short-term functional outcome following elective surgery for complicated sigmoid diverticular disease: sutured or stapled end-to-end anastomosis to the proximal rectum?

OBJECTIVE: The aim of this retrospective non-randomized study was to evaluate the short-term functional outcome following elective resectional surgery for complicated sigmoid diverticular disease, and to compare results of patients having hand-sewn or stapled end-to-end colonic anastomosis to the proximal rectum. PATIENTS AND METHODS: Between 1983 and 1995, of 182 consecutive patients referred to our Institution for surgical treatment of complicated sigmoid diverticular disease, 137 underwent elective left hemicolectomy with primary colonic anastomosis to the proximal rectum, at a level above the peritoneal reflection. Twenty-one patients were excluded from the study because of a covering stoma (n=15), or a side-to-end (n=5) or side-to-side (n=1) anastomosis. All remaining 116 patients had an end-to-end anastomosis without covering stoma. Two groups were compared according to the type of anastomosis performed. Group I comprised the 67 patients who had a hand-sewn anastomosis, and group II the 49 patients whose anastomosis was stapled. Outcome was assessed at 6 months after surgery and compared in the two groups. Assessment included specific morbidity (anastomotic leakage, haemorrhage, fistulation and stenosis, pelvic sepsis), faecal incontinence, constipation, dyschesia, daily stool frequency, and stool consistency. RESULTS: Preoperative patient details were comparable in both groups. There was no post-operative mortality, and the general morbidity rate was similar in both groups (P=0.85). There was no anastomotic leakage or haemorrhage, and no fistulation or pelvic sepsis in either group. One patient in group I, and two from group II, developed flatus incontinence, and a further patient from group II developed incontinence to liquid stool (P=0.17, group I vs group II). We observed better functional outcome following hand-sewn anastomosis. Three group II patients developed anastomotic stenosis compared with none in group I (P=0.04). Constipation (9% vs 28%, P=0.005) and dyschesia (18% vs 39%, P=0.03) were more frequent in group II. Excluding constipated patients (n=20), daily stool frequency was lower (mean 1.2 +/- 0.6 vs 2 +/- 1.3, P=0.0002), and more frequently of normal consistency (79% vs 43%, P=0.0001) in group I. Subgroup analysis failed to show significant differences in functional outcome in both groups in relation to the specific indications for surgery. CONCLUSION: These retrospective data suggest for the first time in the reported literature that hand-sewn colonic anastomosis to the proximal rectum provides a better short-term functional outcome than stapled anastomosis following elective resectional surgery for complicated sigmoid diverticulosis.

Results of behavioral treatment (biofeedback) for solitary rectal ulcer syndrome.

BACKGROUND: Treatment of solitary rectal ulcer syndrome with behavioral techniques (biofeedback) has been shown to be successful in a majority of patients in the short term. We aimed to determine the longer-term outcome of patients treated with this therapy. PATIENTS AND METHODS: Thirteen consecutive patients (3 male; median age, 34 years) with solitary rectal ulcer who had been treated by biofeedback and assessed a median of nine months after treatment were reassessed by questionnaire. Three patients were also examined using rigid sigmoidoscopy. RESULTS: Median follow up was 36 (range, 32-59) months after initial biofeedback treatment. One patient (previously reported as failing biofeedback therapy) was lost to follow-up. Of the four patients previously reported as asymptomatic, one remained asymptomatic, one maintained marked improvement, and another slight improvement; one had reverted to pretreatment status. Of the three patients previously reported as having marked improvement, one maintained moderate improvement, and two had reverted to pretreatment status. The patient previously reporting slight improvement had reverted to pretreatment status. Of the five previously reported failures, two patients experienced no improvement after further courses of biofeedback. At the three different times of review (pretreatment vs. 9 months vs. 36 months after biofeedback), reported bowel function was as follows: the need to strain (12 vs. 5 vs. 9 patients), anal digitation (10 vs. 3 vs. 8 patients), laxative use (9 vs. 4 vs. 4 patients), median time spent in the toilet per attempt at defecation (30 vs. 10 vs. 25 minutes), median visits to the toilet (5.5 vs. 2 vs. 4 per day), and ability to maintain employment (3 vs. 7 vs. 6 patients). CONCLUSION: Improvement in symptoms of solitary rectal ulcer syndrome after biofeedback retraining deteriorates in some patients with time. Half the patients with an early clinical response to retraining, however, can be expected to have ongoing clinical benefit at a median of three years.

Prospective assessment of accuracy of endoanal MR imaging and endosonography in patients with fecal incontinence.

OBJECTIVE: Endoanal MR imaging was prospectively compared with anal endosonography to determine any superiority in the characterization of sphincter morphology in fecal incontinence. SUBJECTS AND METHODS: Fifty-two consecutive patients with fecal incontinence were examined with anal endosonography and endoanal MR imaging after a detailed bowel history, clinical examination, and complete anorectal physiologic testing. External and internal anal sphincter integrity was noted on both endosonograms and MR images by two radiologists in consensus, who read individual scans in a random order to avoid recall bias. Imaging findings were subsequently compared, and arbitration of any disagreement between endosonography and MR imaging was made in consensus by a surgeon and a gastroenterologist who also had access to the patient's history, clinical examination, and anorectal physiologic testing results. RESULTS: Complete agreement was found between anal endosonographic and MR imaging interpretations in 32 patients (62%): 10 with combined external and internal sphincter injuries, two with isolated internal sphincter injury, and 20 with intact sphincters. Of 20 patients in whom results of the scans were disparate, incorrect interpretation was found on endosonography in six patients, on MR imaging in 15. Overall, one error relating to the internal sphincter was made on endosonography versus 12 on MR imaging (p = 0.002), and five errors relating to the external sphincter were made on endosonography versus six on MR imaging (p = 1.0). CONCLUSION: This study suggests that endoanal sonography and endoanal MR imaging are equivalent in diagnosing external anal sphincter injury, but MR imaging is inferior in diagnosing internal anal sphincter injury.

Reassessing artificial bowel sphincters.

The artificial sphincter has now been used for the treatment of patients with faecal incontinence since 1996. Presently, results in the UK do not match those reported from the rest of Europe, with infection caused by methicillin-resistant Staphylococcus aureus being the most common cause of failure.

Permanent sacral nerve stimulation for fecal incontinence.

OBJECTIVE: To characterize the longer-term therapeutic response of permanent sacral nerve stimulation for fecal incontinence and to delineate suitable indications and the mode of action. SUMMARY BACKGROUND DATA: A single report of permanent sacral nerve stimulation in three patients followed up for 6 months showed marked improvement in fecal continence. Acute evaluation has shown that the effect may be mediated by altered rectal and anal smooth muscle activity, and facilitation of external sphincter contraction. METHODS: Five women (age 41-68 years) with fecal incontinence for solid or liquid stool at least once per week were followed up for a median of 16 months after permanent implantation. All had passive incontinence, and three had urge incontinence. The cause was scleroderma in two, primary internal sphincter degeneration in one, diffuse weakness of both sphincters in one, and disruption of both sphincters in one. RESULTS: All patients had marked improvement. Urgency resolved in all three patients with this symptom. Passive soiling resolved completely in three and was reduced to minor episodes in two. Continence scores (scale 0-20) improved from a median of 16 before surgery to 2 after surgery. There were no early complications, and there have been no side effects. One patient required wound exploration at 6 months for local pain, and a lead replacement at 12 months for electrode displacement. The quality of life assessment improved in all patients. The resting pressure increased in four patients, but there was no consistent measured physiologic change that could account for the symptomatic improvement. CONCLUSIONS: In patients with sphincter degeneration and weakness, and possibly in those with sphincter disruption, sacral nerve stimulation markedly improves fecal incontinence.

Long-term results of overlapping anterior anal-sphincter repair for obstetric trauma.

BACKGROUND: Anterior structural damage to the anal sphincter occurs in up to a third of women at first vaginal delivery, and of these a third have new bowel symptoms. The standard treatment for such structural damage is anterior overlapping anal-sphincter repair. We aimed to assess the long-term results of this operation. METHODS: We assessed the long-term results in 55 consecutive patients who had had repair a minimum of 5 years (median 77 months [range 60-96]) previously. Questionnaire and telephone interview assessed current bowel function and continence, restriction in activities related to bowel control, and overall satisfaction with the results of surgery. 42 of these patients had been continent of solid and liquid stool at a median of 15 months after the repair. FINDINGS: We were able to contact 47 (86%) of the 55 patients. One of these patients had required a proctectomy and end ileostomy for Crohn's disease. Of the remaining 46 patients, 27 reported improved bowel control without the need for further surgery, and 23 rated their symptom improvement as 50% or greater. Seven patients had undergone further surgery for incontinence and one patient had not had a covering stoma closed. Thus, the long-term functional outcome of the sphincter repair alone could be assessed in 38 patients. Of these patients, none was fully continent to both stool and flatus; only four were totally continent to solid and liquid stool; six had no faecal urgency; and eight had no passive soiling. Of the 38 patients, 20 still wore a pad for incontinence and 25 reported lifestyle restriction. 14 reported the onset of a new evacuation disorder after sphincter repair. 23 of the 46 patients contacted had a successful long-term outcome (defined as no further surgery and urge faecal incontinence monthly or less). INTERPRETATION: The results of overlapping sphincter repair for obstetric anal-sphincter damage seem to deteriorate with time. Preoperative counselling should emphasise that although most patients will improve after the procedure, continence is rarely perfect, many have residual symptoms, and some may develop new evacuation disorders.

Effect of acute changes in sacral nerve stimulation amplitude on anorectal function in faecal incontinence.

OBJECTIVE: Sacral nerve stimulation improves faecal continence. Preliminary evidence suggests that the effect may be mediated via altered rectal and anal smooth muscle activity, as well as facilitation of external sphincter contraction. Clinical benefit however, appears unrelated to whether stimulation amplitude is above or below that required to produce threshold perineal sensation. Formal evaluation of the effect of different levels of stimulation has not been undertaken. This study aimed to assess the effect of varying stimulation amplitude on pelvic floor motor and sensory function in patients permanently implanted for faecal incontinence. PATIENTS AND METHODS: Three female patients with passive faecal incontinence secondary to internal sphincter weakness, rendered continent with a permanently implanted sacral nerve stimulating electrode and pulse generator a mean of 19 months previously, were assessed. Patients underwent a series of anorectal physiological tests whilst stimulating amplitude was altered but all other stimulation parameters were kept constant. Baseline studies were initially performed at the stimulation amplitude providing continence over recent months for individual patients. Amplitude was then initially reduced, and then increased, in increments of 0.2 V, initially down to zero, and then to the maximal tolerated stimulation amplitude, at which pain was felt. Anorectal physiological testing was repeated 10 min after adjustment to each new amplitude of stimulation. RESULTS: Procedures were well tolerated by all patients. There were no significant differences in any of the physiological variables measured dependent upon intensity of stimulation between zero and the maximum tolerated stimulation. The recto-anal inhibitory reflex was unaltered in the one patient in whom it was demonstrable prior to stimulation. CONCLUSION: Acute changes in stimulation amplitude alone do not produce acute measurable differences in standard anorectal physiological variables. The clinical benefits of sacral nerve stimulation for faecal incontinence are not mediated primarily by improvement in anal canal pressures or alteration of anorectal sensation. Trials of different stimulation parameters over weeks or days may be necessary to demonstrate other functional differences.

Dynamic graciloplasty in the treatment of patients with faecal incontinence.

BACKGROUND: Dynamic graciloplasty is a recent innovation in the surgical management of faecal incontinence. This study reports further experience with this procedure in a series of consecutive patients. METHODS: Between July 1994 and February 1998, 21 dynamic graciloplasties were performed in 18 patients with total faecal incontinence. The two most recent patients were excluded because of follow-up less than 6 months. Continence scores and manometric data were collected before operation and 6 months afterwards. Subsequent clinical data were obtained at regular outpatient review. Seven patients had a three-stage procedure (vascular delay and stoma creation; gracilis transposition and implantation of stimulator and leads; stoma closure), four patients had a two-stage procedure (stoma, with transposition and implantation; stoma closure) and five underwent a one-stage procedure without defunctioning stoma. RESULTS: Mean(s.d.) follow-up was 20(10.2) months, and was complete in all patients. Eight of the 16 patients had postoperative morbidity. Thirty-three subsequent admissions and 23 reoperations were required to treat complications, to correct technical problems or to manage outcome failures. A defunctioning stoma did not protect wounds from infection (P = 0.6) or reduce the postoperative morbidity rate (P = 0.14). Continence scores were improved by the procedure (P < 0.001) and anal canal pressure increased with stimulation (mean increase 35.9 cmHO, P < 0.001). Two patients required revisional surgery for perielectrode fibrosis. Five patients had revisional surgery for electrical device failure. Thirteen of the 16 patients were either improved or fully continent after operation, and satisfied with the result of the procedure. Ultimate failure (n = 3) occurred in patients with chronic preoperative constipation or diarrhoea, or abnormal rectal sensitivity. CONCLUSION: Dynamic graciloplasty is an effective procedure in selected cases of end-stage faecal incontinence. Patient motivation is essential given the necessity for close follow-up.

De Palma staple to fix the tendon in stimulated graciloplasty.

PURPOSE: This new technique fixes the gracilis tendon to the ischial tuberosity. METHOD: The De Palma stapler was used to fix the gracilis tendon to the ischial tuberosity in five patients undergoing stimulated graciloplasty. RESULT: Successful fixation was achieved in all cases with good follow-up. CONCLUSION: This is a simple method that could be adopted widely to fix the gracilis tendon to the ischial tuberosity.